JP3210573B2 - Method for forming thin film at mouth of synthetic resin container for infusion - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for forming a thin film at the mouth of a synthetic resin container for infusion, which comprises closing the mouth of the synthetic resin container for infusion by blow molding and simultaneously forming a thin film at the closing portion. About.

[0002]

2. Description of the Related Art In general, a drug filled in a synthetic resin container for infusion must be tightly sealed in a strict aseptic condition until immediately before use from the viewpoint of hygiene and safety. For this reason, for example, as disclosed in Japanese Patent Publication No. 3-28944 and Japanese Patent Publication No. 7-29336, a rubber stopper and a synthetic resin are usually provided at the mouth where liquid leakage is likely to occur in order to ensure complete prevention of liquid leakage. The mouth plug made of is used together.

[0003] In Japanese Patent Publication No. 3-28944, a synthetic resin spout for keeping the container hermetically sealed and a rubber plug for preventing liquid leakage are sequentially fitted into the mouth of the synthetic resin container for infusion. Is superimposed. The upper portion of the mouth and the upper portion of the synthetic resin plug are heated and pressed by using a welding heater or the like, whereby the upper portions are curved and integrated inward, and the rubber plug is fixedly supported. In this case, the central portion of the synthetic resin stopper is formed in a thin and thin film so that an injection needle or the like easily penetrates and a coring phenomenon does not occur.

In Japanese Patent Publication No. 7-29336,
There is disclosed a method of forming a membrane of an infusion stopper into an extremely thin film.

Further, Japanese Utility Model Laid-Open Publication No. 3-94234 discloses an upper lid body separately formed on a lower lid body (corresponding to the synthetic resin stopper) having a sealing film disposed on an upper end opening edge. There is disclosed an apparatus which is inserted and fitted on a film for sealing via a rubber stopper, and which are welded and integrated by ultrasonic heating or the like.

In addition, Japanese Utility Model Publication No. 4-22745, Japanese Patent Publication No.
In JP-A-49262 and JP-B-5-72830, powdery or lyophilized preparations are stored in vials or other containers as dissolution-in-use preparations for ensuring the stability of pharmaceuticals. Immediately before using the container such as the vial and the container containing the dissolving solution such as water for injection or physiological saline, using a connecting means such as a double-ended needle or a connecting tube having vertically connected needles communicating with each other. A kit container has been proposed in which the drug is dissolved in a dissolving solution by connecting the same.

Further, Japanese Patent Publication No. 5-72830 and Japanese Patent Application Laid-Open No. 7-40425 each disclose a plug member having a penetration means for use to prevent mixing of a solution and a chemical until use. Discloses a fluid passage portion and a plug member which are blocked by the plug.

In Japanese Patent Publication No. 5-72830, a capsule is connected to a flexible container having a fluid passage closed at the upper end with a closing film, and the mouth is sealed with a pierceable stopper. Is held in the capsule. Further, as a communicating means for communicating the inside of the flexible container with the inside of the medicine container, a hollow puncture needle having a hub in the middle and cutting edges at both ends is required. Then, after the stopper of the medicine container is pierced by one blade of the puncture needle, the control means for controlling the communication order so that the closing membrane of the flexible container is pierced by the other blade of the puncture needle. The required infusion container is disclosed.

The solution container of the kit container is preferably made of synthetic resin from the viewpoints of easiness of disposal, safety and economy, and especially for use in a closed system, a bag container made of synthetic resin is preferred. Alternatively, it is preferable to use a soft synthetic resin container manufactured by blow molding. Therefore, Japanese Patent Publication No. 6-61845 and the like disclose a puncture member for use in two film sheet materials or inflation tube materials in order to attach a plug member provided with a penetration means at the time of use such as a thin film to a bag or a soft container. The plug member formed with the sealing thin film formed therethrough is inserted. Thereafter, an inflation method is disclosed in which welding is performed using a heat seal or a high-frequency seal. Also, Japanese Unexamined Patent Publication No. Hei.
No. 9 discloses a method of attaching the plug member to two sheet-like parisons or tubular parisons and performing blow molding to attach the plug member.

On the other hand, JP-A-7-68627 discloses that
In the blow molding, a method is disclosed in which a parison end of a parison is pressed and deformed by a rod operably provided in an air blowing nozzle to form a thin film on the parison end.

[0011]

[Problems to be Solved by the Invention] Japanese Patent Publication No. 3-28944
No. 7, Japanese Patent Publication No. Hei 7-29336, and Japanese Utility Model Laid-Open No. 3-94234, particularly in the mouth where liquid leakage is likely to occur,
Rubber stoppers and synthetic resin stoppers are used together to ensure complete prevention of liquid leakage. Therefore, there are problems in that the number of component parts of the container is large, the production of the infusion container is troublesome, the manufacturing apparatus is complicated, and the cost is high. In addition, these plug members and the like have a danger that welding defects are likely to occur during welding.

In a kit container in which a drug is dissolved at the time of use in order to ensure the stability of the drug, etc., the solution filled in the solution container is filled into the container containing the drug by using a double-ended needle or a connecting tube. Transported and mixed and dissolved. However, this mixing and dissolving operation is complicated and time-consuming, and the double-ended needle and the connecting tube come into contact with the outside air, so that there is a problem that the drug and the dissolving solution are easily contaminated with various bacteria.

Therefore, a kit container has been proposed in Japanese Utility Model Publication No. 4-22745 in which a double-ended needle is previously housed in a protective cap above a cap-shaped rubber stopper fitted to the narrow neck opening of the solution container main body. Further, Japanese Patent Publication No. 3-49262 discloses that a container such as a vial containing a dissolving-type drug at the time of use and a flexible container filled with a dissolving solution are previously arranged vertically with a puncture needle such as a double-ended needle interposed therebetween. A kit container disclosed in Japanese Patent Publication No. Hei 5-72830 has also been proposed.

[0014] Japanese Utility Model Publication No. 4-22745 and Japanese Patent Publication No.
In the kit containers disclosed in JP-A-49262 and JP-B-5-72830, since a plug member provided with a penetrating means at the time of use such as a thin film is required, the number of component parts of the container is large,
There are similar problems as described above.

Also, Japanese Patent Publication No. Hei 6-61845,
In each of JP-A-92479, it is necessary to insert or insert a plug member formed with a sealing thin film that is pierced by a puncturing member at the time of use. There is.

In JP-A-7-68627, since a thin film for closing the mouth is formed by integral molding, the danger of poor welding is avoided, but a rod operable inside the air blowing nozzle is provided. Since the body is provided, the configuration of the air blowing nozzle is complicated. Further, since the diameter of the air blowing nozzle becomes large, there is a problem that a container having a small diameter at the mouth cannot be formed.

According to the present invention, a thin film is formed at the same time as the mouth is closed by blow molding, the number of parts is small, there is no danger of liquid leakage due to poor welding, and the invasion of various bacteria by carrying in a separate plug member. An object of the present invention is to provide a method of forming a thin film at the mouth of a synthetic resin container for infusion which is not feared.

Further, according to the present invention, there is no need to provide an operable rod inside the blowing nozzle, the diameter of the blowing nozzle can be reduced, and the present invention is suitable for forming a container having a small mouth. An object of the present invention is to provide a method of forming a thin film at the mouth of a synthetic resin container for infusion.

[0019]

In order to solve the above-mentioned problems, a method for forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention comprises inserting a molten tubular parison into a mating mold for blow molding, and blowing the same. Insert the nozzle into the neck of these molds and let the fused resin in the neck protrude in the direction of the inner diameter of the tubular parison as the synthetic resin overhang at the mouth of the mold for blow molding. A thin film forming die is protruded so as to protrude, and a mouth forming die is inserted into a mouth of a blow molding mating die, and the thin film forming die is extruded into a mouth of a blow molding mating die and blown. It is characterized in that a thin film is formed by using an embedding nozzle and a thin film forming stamp.

[0020]

[0021]

[0022]

[0023]

[0024]

Further, in the method for forming a thin film at the mouth of a synthetic resin container for infusion, a dish-shaped dent is formed on the inner peripheral edge of the tip surface of the mold for forming a mouth, and the dish-shaped dent and the periphery of the thin film-forming stamp are formed. An annular projection is formed in the peripheral portion of the thin film by forming an annular recess between the thin film and the thin film.

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The method for forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention will be described below in detail with reference to the accompanying drawings.

1 to 3 show a front view, a bottom view, and a side view, respectively, of the infusion synthetic resin container obtained by carrying out the present invention, and FIG. 4 shows the infusion synthetic resin container shown in FIG. FIG. 2 shows a cross-sectional view taken along line AA. 5 to 8 show stepwise a method of forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention.

The heat-melted thermoplastic synthetic resin is inserted, for example, by extrusion into a tube-shaped parison 3 into the blow molds 2 and 2 of the synthetic resin container 1 for infusion, and heated to soften. State.

Next, the blowing nozzle 4 is inserted into the neck portions 21 and 21 of the blow molds 2 and 2, and the heated and melted parison 3 is shouldered from the neck portions 21 and 21 of the molds 2 and 2. The parison 3 is pushed out by the nozzle 4 while being brought into close contact with the parts 22 and 22.

The synthetic resin forming the tubular parison 3 in close contact is extruded by the nozzle 4 so that the synthetic resin overhanging portion 5 overhangs the inner surface of the parison 3 in the mouths 23 of the mating dies 2. Is provided.

Further, the mouths 23 of the mating dies 2, 2
A concave portion 72 is formed in the center of the front end surface 71, into which the thin plate forming die 6 in an inverted dish shape (in a state where the plate is turned over) is inserted, and the pressing die 6 is pushed out from the front end surface 71 to be freely extruded. The formed die 7 for forming a mouth is provided.

When the thin film forming die 6 is fitted into the concave portion 72, the front end surface 71 of the mouth forming die 7 and the tip of the thin film forming die 6 are flush with each other.
Then, a dish-shaped recess 73 slightly larger in diameter than the recess 72 is formed.

Then, as shown in FIG. 7, the opening forming die 7 in which the thin film forming pressing die 6 is fitted in the concave portion 72 is inserted into the opening portions 23 of the mating dies 2 and 2 to form a thin film. The pressing die 6 is inserted into the mouth portions 23, 23.

When the mold 7 for forming a mouth and the mold 6 for forming a thin film are inserted into the mouths 23, 23, as shown in FIG. , 7 to fill the remaining gap, the die 6 and the blowing nozzle 4
Then, the thin film 8 is formed at the tip.

An annular concave portion 9 is formed by a peripheral portion of the pressing die 6 protruding from the concave portion 72 on the distal end surface 71 of the pressing die 7 and a dish-shaped concave portion 73 formed on the distal end surface 71. Filling the annular projection 9
Mold 1.

After forming the mouth with the thin film, the blowing nozzle retracts, and instead, a chemical filling nozzle (not shown) is inserted into the synthetic resin container for infusion to fill with the chemical, and thereafter The insertion opening is sealed by, for example, heating and welding with a mold or the like, and the opening 10 is formed to obtain a synthetic resin container 1 for infusion. At this time, it is preferable that a thin portion for breaking is provided in the mouth portion 10 not provided with the thin film so as to be easily opened at the time of use.

Alternatively, the mouth portion 10 of the synthetic resin container 1 for infusion, which is not provided with a thin film, is provided with a thin portion for breaking, for example, as disclosed in Japanese Patent Application Laid-Open No. Using a method described in JP-A-137160, the mouth stopper is heated after molding, and the rubber stopper 11 for preventing liquid leakage during use is used
Is inserted under pressure. Thereby, the synthetic resin overhanging portion formed at the upper portion of the container mouth portion 10 is pressed by using a pressing mold to bend inward, and the end of the synthetic resin overhanging portion is inserted into the annular concave portion on the outer peripheral portion of the rubber stopper upper surface. It may be a fitting entrance (FIG. 9).

The mouth provided with the thin film is pierced with a penetrating member such as a double-ended needle, a spike, or an injection needle at the time of use, and is used as a drip solution or the like. Alternatively, the penetrating device 12 at the time of use, which incorporates a chemical solution distribution member such as a double-ended needle, may be heated and welded to form a kit product (FIG. 10).

As a kit product, a use-time penetrating device 12 having a built-in chemical liquid distribution member such as a double-ended needle is connected to the synthetic resin container 1 for infusion, and a hollow double-ended needle provided inside the penetrating device 12 during use is used. After piercing a vial containing a dissolvable solid preparation during use through the chemical liquid distribution member, the chemical liquid distribution member is operated to break the thin film, thereby dissolving the vial with the dissolved liquid in the synthetic resin container 1 for infusion. And the like to obtain a desired drug solution by mixing the solid preparation therein (FIG. 1).
0).

Alternatively, a capsule having a vial accommodating a solid preparation to be dissolved at the time of use is connected to the synthetic resin container 1 for infusion via a liquid passage, and a drug solution such as a hollow double-ended needle provided in the capsule is provided. One in which the dissolving liquid in the synthetic resin container for infusion 1 and the solid preparation in the capsule are mixed by operating the flow member to break the thin film (not shown).

[0041]

According to the synthetic resin container for infusion manufactured by the method for forming a thin film of the mouth according to the present invention, the thin film for sealing the content liquid is integrally formed on the container body, so that there is no need to prepare a separate plug member. In addition, the number of container parts is small, and the working process is simplified. Also, there is no danger of liquid leakage due to poor welding.

Furthermore, since there is no need to use a separate plug member, invasion of various bacteria by carrying the plug member can be prevented.

The mouth provided with the thin film manufactured according to the present invention is provided with an annular projection projecting upward around the periphery of the thin film, so that the annular projection can be used for double-ended needles, spikes, injection needles and the like. Since the piercing member functions as a guide when piercing, the piercing member can be easily and quickly punctured, and there is no possibility of accidentally piercing another part.

The annular projection is also effective as a positioning means when a penetrating device at the time of use, in which a chemical solution distribution member such as a double-ended needle is incorporated in the mouth provided with the thin film, is used.

Furthermore, since the mouth provided with the thin film manufactured according to the present invention forms the thin film by pressing with the blow nozzle and the thin film forming die, the shape of the pressing surface of the blow nozzle and the thin film forming die is changed. By changing the shape, the shape around the thin film portion can be freely processed.

[Brief description of the drawings]

FIG. 1 is a front view of a synthetic resin container for infusion obtained according to the present invention.

FIG. 2 is a bottom view of a synthetic resin container for infusion obtained according to the present invention.

FIG. 3 is a side view of a synthetic resin container for infusion obtained according to the present invention.

FIG. 4 is a sectional view taken along line AA of FIG. 2;

FIG. 5 shows a method for forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention, in which a parison is inserted into a blow mold.

FIG. 6 shows a method of forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention, in which a blowing nozzle is inserted into a neck portion of a mold for blow molding.

FIG. 7 shows a method of forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention, in which a die for forming a mouth is just inserted into a mouth of a mating die for blow molding.

FIG. 8 shows a method for forming a thin film at the mouth of a synthetic resin container for infusion according to the present invention, in which a mold for forming a mouth and a mold for forming a thin film are inserted into the mouth of a mating mold for blow molding. Things.

FIG. 9 is a cross-sectional view taken along the line AA of FIG. 4 of a synthetic resin container for infusion of the present invention, in which a rubber plug for preventing liquid leakage during use is pressurized and inserted into the mouth of the synthetic resin container having no thin film. is there.

FIG. 10 is a press-fitted rubber stopper for preventing leakage when used in the mouth of the synthetic resin container for infusion of the present invention, which is not provided with a thin film, and further, a medical fluid distribution member is inserted into the mouth provided with the thin film. It is a front view of what attached the penetration device in use built in.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Synthetic resin container for infusion 2 Mold for blow molding 21 Neck 22 Shoulder 23 Mouth 3 Parison 4 Blow-in nozzle 5 Synthetic resin overhanging part 6 Thin film forming mold 7 Mold forming mold 71 Tip surface 72 Recess 73 Dish-shaped recess 8 thin film 9 annular recess 91 annular projection 10 mouth 11 rubber stopper 12 penetration device when used

Claims (2)

(57) [Claims] 1. A molten tubular parison is inserted into a mold for blow molding, a blowing nozzle is inserted into the necks of these molds, and the molten resin in the neck is fed to the mouth of the mold for blow molding. At the mouth of the blow mold, a mouth-forming mold that protrudes as a synthetic resin overhang in the inner diameter direction of the tubular parison as a synthetic resin overhang, and protrudes freely from the tip of the inverted plate-shaped thin film forming die A thin film forming part for a synthetic resin container for infusion characterized in that the thin film forming die is inserted and extruded into an opening of a blow molding mating die, and a thin film is formed by a blow nozzle and a thin film forming die. Method. 2. A thin plate is formed by forming a dish-shaped recess in the inner peripheral edge of the tip end surface of the mouth forming die and forming an annular recess between the dish-shaped recess and the periphery of the thin film forming die. 2. A method for forming a thin film at the mouth of a synthetic resin container for infusion according to claim 1, wherein an annular projection is formed on the periphery.